In een uitgebreid artikel in het Bulletin of IACFS/ME doet Tom Kindlon,

gebaseerd op ideeën van de Consolidated Standards of Reporting Trials (CONSORT) group, aanbevelingen voor het rapporteren van de negatieve effekten van CBT/GET in studies.

Benieuwd of vermoeidheidsdeskundigen in Nederland en België die uitdaging aandurven...

Tom analyseert onderzoek onder ME/CVS-patiënten naar ervaringen met CBT/GET [75,78-84]. Op basis van die analyse komt hij tot de volgende schokkende cijfers:

1. This includes any degree of harm e.g. both "somewhat worse " and "a lot worse " from the ME Association survey [85].
2. Taken from [75, 78-80, 82-85].
3. Taken from [80, 81, 83-85].
4. Taken from [79, 80, 83-85].

75. 25% ME Group. Severely Affected ME (Myalgic Encephalomyelitis) Analysis Report On Questionnaire Issued January 2004. Troon, Scotland. March 2004.

76. ..

77. ..

78. ME Action. ME Action Survey (1990). Cited by: Shepherd C. Living with M.E.: The Chronic, Post-viral Fatigue Syndrome. London, England: Cedar Books;1992:224.

79. 1999 Chronicle Reader Survey. Charlotte, NC: CFIDS Association of America. CFIDS Chronicle. 1999;12(4):9.

80. Action for M.E. Severely Neglected: M.E. in the UK-Membership Survey. London: Action for M.E.; 2001.http://www.docstoc.com/docs/21870572/Sev-Neglected. Accessed September 16, 2011.

81. Koolhaas MP, de Boorder H, van Hoof E (2008). Cognitive behaviour therapy for chronic fatigue syndrome from the patient’s perspective [Cognitieve gedragstherapie bij het chronische vermoeidheidssyndroom (ME/CVS) vanuit het perspectief van de patiënt] [Dutch]. Medisch Contact. ISBN: 978-90-812658-1-2. Available at: http://home.planet.nl/~koolh222/cgtbijmecvsvanuitperspectiefpatient2008.pdf Accessed September 16, 2011.

82. Action for ME and Association of Young People with ME. ME 2008: What progress? 2008 May. Available at: http://www.ayme.org.uk/files/MEAW2008-report.pdf. Accessed: September 16, 2011.

83. Veer, A.J.E. de, & Francke, A.L. (2008). Zorg voor ME/CVS-patiënten. Ervaringen van de achterban van patiëntenorganisaties met de Gezondheidszorg. Utrecht: NIVEL. http://www.nivel.nl/pdf/Rapport-draagvlakmeting-CVS-ME-2008.pdf. Accessed September 16, 2011.

84. Bjørkum T, Wang CE, Waterloo K. [Patients' experience with treatment of chronic fatigue syndrome.] Tidsskr Nor Laegeforen. 2009 Jun 11;129(12):1214-6

Reporting of harms associated with graded exercise therapy and cognitive behavioural therapy in myalgic encephalomyelitis/chronic fatigue syndrome.

Bulletin of the IACFS/ME. 2011;19(2): 59-111.

Kindlon, T.

Tom Kindlon

Information Officer (voluntary position)

Irish ME/CFS Association

PO Box 3075,

Dublin 2,

Rep. of Ireland

ABSTRACT

Across different medical fields,

authors have placed a greater emphasis on the reporting of efficacy measures

than harms in randomised controlled trials (RCTs),

particularly of non-pharmacologic interventions.

To rectify this situation,

the Consolidated Standards of Reporting Trials (CONSORT) group and other researchers

have issued guidance to improve the reporting of harms.

Graded Exercise Therapy (GET) and Cognitive Behavioural Therapy (CBT)

based on increasing activity levels

are often recommended for

Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS).

However,

exercise-related physiological abnormalities

have been documented in recent studies and

high rates of adverse reactions to exercise

have been recorded in a number of patient surveys.

Fifty-one percent of survey respondents (range 28-82%, n=4338, 8 surveys)

reported that GET worsened their health

while 20% of respondents (range 7-38%, n=1808, 5 surveys)

reported similar results for CBT.

Using the CONSORT guidelines as a starting point,

this paper identifies problems with the reporting of harms in previous RCTs and

suggests potential strategies for improvement in the future.

Issues involving

the heterogeneity of subjects and interventions,

tracking of adverse events,

trial participants’ compliance to therapies, and

measurement of harms

using patient-oriented and objective outcome measures

are discussed.

The recently published PACE

(Pacing, graded activity, and cognitive behaviour therapy: a randomised evaluation) trial

which explicitly aimed to assess "safety"", as well as effectiveness,

is also analysed in detail.

Healthcare professionals, researchers and patients

need high quality data on harms

to appropriately assess the risks versus benefits of CBT and GET.

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